single-dose islatravir in moderate hepatic impairment (mk-8591-030)

Conditions: Human Immunodeficiency Virus (HIV) Infection

Summary: this is an open-label, single-dose study of the plasma pharmacokinetics (pk), safety, and tolerability of islatravir (isl, mk-8591), and the intracellular pk of isl triphosphate (isl-tp) in male and female adult participants with moderate hepatic impairment and in healthy matched control participants.


Eligibility criteria:
inclusion criteria: healthy control participants: * is in good health based on medical history, physical examination, vital sign (vs) measurements and electrocardiograms (ecgs) performed prior to randomization * is in good health based on laboratory safety tests obtained at the screening visit and prior to administration of the initial dose of study drug. * has a body mass index (bmi) ≥18.5 and ≤40 kg/m2 hepatic impairment participants: * has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology * has a score on the child-pugh scale ranging from 7 to 9 (moderate hepatic insufficiency) at screening * with the exception of hepatic impairment, is in generally good health * has a bmi ≥ 18.5 and ≤ 40 kg/m2 healthy and hepatic impairment participants: * males : uses contraception according to local regulations * females: is not pregnant or breastfeeding and one of the following applies: * is not a woman of childbearing potential (wocbp) or * is a wocbp and uses an acceptable contraceptive method * a wocbp with negative highly sensitive pregnancy test within 24 hours of study intervention exclusion criteria: * has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years * has a history of cancer (malignancy) * has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or non-prescription drugs or food * has known hypersensitivity to the active substance or any of the excipients of the study drug * is positive for hepatitis b surface antigen, hepatitis c antibodies, hiv-1 or hiv-2 * had major surgery, donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the prestudy (screening) visit * is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to study drug administration, throughout the study, until the poststudy visit * has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit * has a qtc interval \>470 for males or \>480 ms for females, has a history of risk factors for torsades de pointes (eg, heart failure/cardiomyopathy or family history of long qt syndrome), has uncorrected hypokalemia or hypomagnesemia, is taking concomitant medications that prolong the qt/qtc interval * is not considered low risk of having hiv infection * is a smoker or user of electronic cigarettes and/or has used nicotine or nicotine-containing products (eg, nicotine patch) within 3 months of screening * consumes greater than 3 glasses of alcoholic beverages per day * consumes more than 6 caffeinated beverages per day * is a regular user of illicit drugs or has a history of drug abuse within 2 years * presents any concern to the investigator regarding safe study participation * is unwilling to comply with study restrictions * is or has an immediate family member who is investigational site or sponsor staff directly involved with this study